FDA aproves Finacea for topical treatment of rosacea

MONTVILLE, N.J., Jan. 2, 2003 -- Berlex Laboratories, the U.S.
affiliate of Schering AG, Germany, announced that the FDA has
approved Finacea (azelaic acid) Gel 15 percent for the topical
treatment of the inflammatory papules and pustules of mild to
moderate rosacea. Finacea is the first new therapeutic option to be
approved for the treatment of rosacea in more than a decade.

Results of two multi-center, randomized, double blind, Phase III
studies involving 664 patients showed that Finacea had a
significantly greater efficacy than its vehicle in reducing the
number of inflammatory papules and pustules associated with
rosacea. Significant treatment effects were discernible as early as
four weeks and progressive improvement continued to be shown week
after week in the two 12-week studies. These findings were included
in the New Drug Application (NDA) filed with the FDA in March 2002.
Both protocols were identical.

"Prior to the FDA approval of Finacea, Rosacea patients had
waited more than a decade for a new treatment for this chronic
condition. We now have the opportunity to address that unmet need"
said Elise Klein, Vice President and General Manager, Dermatology,
Berlex Laboratories, Inc. "The approval also is an important
milestone in Berlex Dermatology's commitment to building our
product portfolio in the United States," she added.

Finacea contains azelaic acid, a naturally occurring saturated
dicarboxylic acid. Azelaic acid is a white, odorless crystalline
solid that is poorly soluble in water, but well soluble in alcohol.
The formulation of Finacea provides improved drug penetration
compared with the cream formulation. Although the exact mechanism
of Finacea is not fully understood, clinical studies have shown
that it interferes with the pathogenic events in rosacea. An
anti-inflammatory effect was found in vitro.

Rosacea, characterized by initial episodic reddening and later
persistent redness and inflammatory lesions, affects more than 13
million American adults between the ages of 30 and 50; however,
physicians estimate this number may be higher. In many cases,
people who suffer from rosacea are unaware of the condition and do
not seek medical treatment in its early stages.

While rosacea can affect anyone, fair-skinned individuals are
more susceptible to the disease. People who have a family history
of rosacea or tendency to flush or blush easily are also more at
risk for the disease. Women are more likely than men to have
rosacea, although the disease is often more severe in men.

Finacea is indicated for topical treatment of inflammatory
papules and pustules of mild to moderate rosacea.

Finacea is contraindicated in individuals with a history of
hypersensitivity to propylene glycol or any other component of the
formulation. The most frequently reported adverse events related to
Finacea included burning/tingling, and itching. These occurred in
more than 10 percent of patients. Events occurring in 1 to 10
percent of patients included dry skin and rash. The majority of
adverse events were mild in severity.

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